h3. Further Class Review by the Pharmacovigilance Working Party (PhVWP) Bisphosphonates are a class of medicinal substances approved for various indications related to their inhibitory effect on bone resorption in certain malignant and benign diseases, including osteoporosis. For detailed information on the approved indications for use, warnings and precautions for use etc. please refer to [...]
Nebivolol (Nebilet) is Now Licensed for the Treatment of Hypertension in the USA
In New York on December 18th 2007, Forest Laboratories, Inc., and Mylan Inc., announced that the novel beta blocker nebivolol (Bystolic) is now licensed for the treatment of hypertension. Nebivolol, trade name Nebilet in Ireland, is already approved and successfully marketed for the treatment of hypertension, in more than 50 countries outside of North America. [...]
Avastin approved in Europe for first-line treatment of patients with advanced kidney cancer
Roche Products (Ireland) Ltd., wish to announce that Avastin (bevacizumab) is approved in EU for the first-line treatment of patients with renal cell carcinoma, the most common form of advanced kidney cancer. Treatment options for patients with kidney cancer are limited. Surgical removal of part or the entire kidney forms the mainstay of treatment but [...]
Efficacy and Tolerability of new Once daily Exelon Transdermal Patch
Novartis Ireland wish to announce the launch of once daily Exelon transdermal patch, for the first line treatment of mild to moderately severe Alzheimer’s dementia (AD). Cholinesterase inhibitors, which act by inhibiting the degradation of acetylcholine in the synapse, form the mainstay of therapy for mild to moderate AD. Exelon (rivastigmine) administered orally is currently [...]
Aclasta Once yearly for Treatment of Postmenopausal Osteoporosis
Novartis Ireland are delighted to announce the availability of Aclasta (zoledronic acid) for the treatment of postmenopausal osteoporosis. Bisphosphonates, the most commonly used treatment for established osteoporosis, inhibit osteoclast-mediated bone resorption and reduce the risk of fracture. However, adherence to oral treatment is often a problem, and about half of patients for whom oral treatment [...]
Products Withdrawn in Ireland in the last 12 Months
The majority of withdrawals have been due to commercial rationalisation decisions.Products highlighted in bold apply to the current month. Benoral Benph Bipreterax Calcort Cardene Cefrom Dicynene Fansidar Femodene Flucandid Intal Kinidin Durules Largactil Liquivisc MXL Melleril Migranat Myocrisin Nuvelle Oestrogel Orudis Piportil Premdoc Psorimed Quinapro Rimactane Rimactizid Rynacrom Sectral Surgam SA Sustanon Tilade Topicycline Triodene
Product Discontinuation Announcements
Byfluc, Calcort, Gyno-Pevaryl, 1 Combipak, Motival, MST Continus 200mg, Vibramycine capsules 50mg, Zerit 15mg have been discontinued. BYFLUC 200MG DISCONTINUED Ergha Healthcare Ltd would like to inform you of the withdrawal of ByFluc 200mg Capsules from the market. ByFluc 200mg Capsules will remain on the market until 31st May 2008 at €70.00 for 7 capsules. [...]
Gygel to replace Ortho-Creme
Janssen-Cilag Ltd would like to inform you that they have discontinued Gyno- Ortho-Crème (nonoxinol-9) at the end of January 2008. They are pleased to announce that an alternative nonoxinol-9 based spermicidal product will be available from Marlborough Pharmaceuticals Ltd. This product is called Gygel and is a contraceptive gel containing 2% nonoxinol-9. All enquiries concerning [...]
Efexor XL, Tazicin, Meningitec Suspension
Wyeth Pharmaceuticals Ltd is pleased to advise you that Efexor XL 37.5mg is now available for the treatment of panic disorder (see New Clinical Evidence). They would also like to inform you that Tazocin (piperacillin/tazobactam) has been reformulated. Tazocin new formulation is now available in your wholesaler and details of the new formulation are available [...]
Tevax
Company: TEVA Pharmaceuticals Ireland. Legal category: Prescription. GMS. Sport Permitted. Active ingredient: Alfuzosin hydrochloride10mg. Description: White, round, bevelled-edges, prolonged releasetablet. Presentation: 30, €18.78. Indications: Moderate to severe functional symptoms of benignprostatic hyperplasia (BPH). Pharmacology: Alfuzosin is an orally acting quinazolin derivative,which selectively blocks post-synaptic alpha-1-receptors and thus relaxessmooth muscle and improves urinary flow. Dosage: Adult: [...]